Quality Assurance

Streamline SOPs. Successful submissions.

Quality is integrated into all of our practices. The PharmaNet QA team interacts directly with clients to understand the specific requirements for their clinical study or drug development project. Together, our quality and regulatory affairs specialists oversee conformance with these client requirements and any applicable regulations such as U.S. Food and Drug Administration (FDA) regulations, Canada’s Health Products and Food Branch Inspectorate regulations, European Union directives, ANVISA and other applicable international agencies’ regulations during each phase of the clinical trial process. Our experience and oversight ensures that our clinical and bioanalytical services comply with applicable Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and International Conference on Harmonisation (ICH) GCP guidelines (E6).

As part of our commitment to continual improvement, we measure, assess and report quality data and seek ways to continually improve quality performance and results. According to industry best practices, our corrective and preventive action (CAPA) process ensures we investigate significant out-of-specification events, deviations and discrepancies, report the findings and conclusions of the investigation and implement and document corrective actions. We maintain preventative maintenance and calibration programs, as applicable, to ensure operational equipment is appropriately maintained and operating as defined.

At the heart of every PharmaNet drug development program is an independent team of dedicated quality assurance (QA) specialists who ensure the credibility of your data. Our senior-level auditors conduct unbiased assessments of all aspects of a study, including auditing clinical sites and associated databases, vendors, validating software, and assuring the quality of individual reports, study files, tables, and listings. They can also provide training to prepare investigator sites for actual regulatory inspections. Because of our global footprint, we have personnel fluent in twelve major languages and have conducted quality assurance audits in more than 45 countries. At PharmaNet, we build quality into all our services.

Quality Assurance services include:
 

Auditing

• Investigator sites
• Clinical and analytical laboratories
• Drug packaging and distributors
• Institutional Review Boards
• Phase I units
• Suppliers/vendor

Validation

• Computer systems
• Databases

Study deliverables

• Protocols
• CRFs
• Clinical study reports
• Study files
• Tables and listings

Regulatory inspection preparedness

• Conduct FDA and MHRA mock regulatory inspections
• Provide training to prepare investigator sites for regulatory inspections
• Assist preparing responses to inspection findings